FDA Issues New Guidance for Testing Pharmaceutical Alcohols for Methanol, Following Hand Sanitizer Recalls

Federal regulators have issued new guidelines for testing alcohol products, including hand sanitizer and certain pharmaceuticals, as part of a continuing effort to reduce the risk of methanol poisoning.

The U.S. Food and Drug Administration (FDA) issued a final guidance, Policy for Testing of Alcohol (Ethanol) and Isopropyl Alcohol for Methanol, on October 17, replacing previous guidance put into place in February 2021, during the COVID-19 pandemic.

This version expands the methanol testing requirements for all products that use pharmaceutical alcohols, not just hand sanitizers, which were the focus of the original guidance issued in 2021.

Methanol is a wood alcohol that can be toxic when absorbed through the skin, such as when consumers use hand sanitizer. It is also life-threatening and can lead to serious health side effects ranging from coma to death when ingested.

The new guidance calls for a methanol limit of 200 parts per million for alcohol (ethyl alcohol or ethanol) and isopropyl alcohol.

Hand Sanitizer Methanol Recalls

The original guidance was issued during the height of the pandemic, when health conditions called for increased production of hand sanitizer, which stressed supply chains and resulted in a number of unsafe products being sold.

The U.S. market saw an influx of methanol-containing hand sanitizers that were not approved for topical use and especially not approved for ingestion. The FDA issued more than 100 recalls for hand sanitizers due to methanol alcohol contamination or lower than disclosed levels of ethanol or isopropyl alcohol.

In the spring of 2020, numerous hand sanitizers were labeled to contain ethanol but tested positive for methanol alcohol contamination. In some cases, consumers drank the hand sanitizer products, leading to methanol poisoning, which was blamed for at least four deaths.

In February 2021, a mother filed wrongful death lawsuit against 4e Brands after her daughter died from ingesting lethal amounts of methanol found in hand sanitizer products.

The issue with methanol-contaminated products wasn’t isolated to hand sanitizer products. The FDA issued a recall of some rubbing alcohol products that were discovered to also contain methanol.

The updated guidance indicates methanol may be a problem in other pharmaceutical and compounding drug products. It calls on manufacturers to know the entities involved in producing the ingredients in the supply chain, including pharmaceutical alcohol.

The FDA said it will continue to issue warning letters to companies for manufacturing products that contain unacceptably high levels of methanol that can pose a threat to public health and safety.

The new guidance was issued effective immediately, without a public comment period.